Packaging Design for Remote Clinical Trial Operations

Abstract

As remote clinical trials continue to revolutionize the old-fashioned clinical trials model and increase patient enrollment, it has become apparent that there is no regulatory framework in place to standardize their utilization. In traditional clinical studies, there is very little independent user control and, therefore, error as a designated clinician performs all physiological measurements on each subject in person. However, in remote clinical settings, there is an added component of having to collect each participant’s physiological data and other necessary information over distance. This introduces the need for a “trial in a box” or remote clinical trial kits. Both the participant and the facilities in charge of the kits play a role in how these kits need to be designed, manufactured, and handled. However, there is a clear lack in the standardization of kit design.

This project provides a framework for human-subjects researchers to establish their own remote clinical trial operations. This thesis, specifically, focuses on designing the clinical trial kits that could be used for the trials mentioned in this case while also detailing design decisions in order to standardize kit design for other remote clinical trials.